US8006701B2 - Device and method for the therapy of obesity - Google Patents

Abstract

An anastomotic device, particularly a circular stapler (10), comprises a handle (12) and a stem (14). A channel suitable to receive a guide wire at least partially develops along the length of the stapler. The stem (14) is made of a flexible material, such as to facilitate reaching the site requiring anastomosis. The circular stapler (10) comprises an anvil (16) suitable to be introduced on the free end of the stem (14). The anvil (16) comprises a channel (22) suitable to receive a guide wire (66) and extending along the anvil, and a portion (20) suitable to act as a striker against the wall of one of the portions (A; B) of the tissues to be joined.

Description

The present invention relates to devices and methods for the therapy of obesity in general. Particularly, the present invention relates to devices for drawing together tissues that are suitable to be used in a method for carrying out anastomosis in tracts of the digestive tube.

According to a further aspect, the present invention relates to a circular stapler, which is also particularly suitable to be used in a method for carrying out anastomosis in tracts of the digestive tube.

The present invention further relates to a method for carrying out anastomosis in tracts of the digestive tube.

At present, surgical anastomoses are very difficult to carry out via endoluminal access. Most of anastomoses, in fact, are created by using open or laparoscopic surgical techniques.

Accordingly, no effective surgical instruments are available which offer the guide and control required to suitably drawing together the tissue surfaces and/or connecting the surfaces with a passage (anastomosis) through the body cavities.

The problem at the heart of the present invention is to provide devices capable of drawing tissues together and create a passage therebetween. A further problem at the heart of the present invention is to provide devices capable of being used in a method for carrying out anastomosis in tracts of the digestive tube with endoluminal access.

This problem is solved by means of a circular stapler according to claim1.

According to a still further aspect, a problem at the heart of the present invention is to provide a method for carrying out anastomoses in tracts of the digestive tube with endoluminal access.

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the devices, circular stapler and method according to the invention will result from the description below of preferred exemplary embodiments, which are given as a non-limiting indication, with reference to the attached figures, wherein:

FIG. 1 illustrates a perspective view of a circular stapler;

FIG. 2 illustrates a perspective view of a device to be associated with the circular stapler fromFIG. 1;

FIG. 2aillustrates a perspective view of the stapler fromFIG. 1, guide wire and device fromFIG. 2 during an assembly step for performing a suture;

FIG. 3 illustrates a perspective view of a possible embodiment of a positioning device;

FIG. 4 illustrates a sectional view along a plane containing a longitudinal axis of the device fromFIG. 3;

FIG. 5 illustrates a perspective view of a detail of the device fromFIG. 3;

FIG. 6 illustrates a perspective view of a detail of the device fromFIG. 3;

FIGS. 7 and 8 illustrate perspective views of the detail fromFIG. 5 from different points of view;

FIG. 9 illustrates a perspective view of a possible embodiment of a positioning device;

FIG. 10 illustrates a sectional view along a plane containing a longitudinal axis of the device fromFIG. 9;

FIG. 11 illustrates a partially sectioned, perspective view of a detail of the device fromFIG. 9;

FIG. 12 illustrates a perspective view of a detail of the device fromFIG. 9;

FIG. 13 illustrates a perspective view of a possible embodiment of a positioning device;

FIG. 14 illustrates a sectional view along a plane containing a longitudinal axis of the device fromFIG. 13;

FIG. 15 illustrates a perspective view of a detail of the device fromFIG. 13;

FIG. 16 illustrates a perspective view of a detail of the device fromFIG. 13;

FIG. 17-40 illustrate several steps of a method according to the present invention;

FIG. 41 illustrates a partial perspective view of a circular stapler, a positioning device and a guide wire, an anchoring ring being inserted thereon;

FIG. 42 illustrates the circular stapler, positioning device and guide wire fromFIG. 41 while the positioning device is being inserted in the circular stapler;

FIG. 43 illustrates theFIG. 41 in a longitudinal section;

FIG. 44 illustratesFIG. 41 from a different point of view.

DETAILED DESCRIPTION

With reference toFIG. 1, with10 has been indicated a circular stapler portion comprising ahandle12 and astem14 as a whole. The structure of the circular stapler is similar to the known circular staplers, which are conventionally used to carry out circular anastomosis, such as of the bowel. The structure of the circular stapler according to the present invention is changed compared with the conventional ones in that, in a preferred embodiment thereof, it has a channel suitable to receive the guide wire. InFIG. 2A, thecircular stapler10 has a channel crossing thestem14 thereof from the distal end to an area at the proximal end from which it protrudes outside, for example on one side. In accordance with different embodiments, not illustrated, the guide wire runs all along the length of the circular stapler or only a distal portion thereof.

The channel is suitable to receive a guide wire (not illustrated inFIG. 1) such that the stapler can slide therealong and be placed in the site requiring anastomosis. An exemplary use of thecircular stapler10 will be described below with particular reference toFIG. 29. The length of thestem14 and the diameter thereof are sufficient to carry out the method and reach the desired site.

Advantageously, the stem is made of a flexible material, such as to facilitate reaching the site requiring anastomosis.

Thestapler10 advantageously comprises ananvil16 illustrated for example inFIG. 2. Theanvil16 defines an exemplary device for drawing tissues together, particularly a device that, besides drawing the tissues together, is suitable to be associated with thecircular anvil10 such as illustrated inFIG. 1 in order to carry out anastomosis.

Theanvil16 comprises astem18 and ahead20. Thestem18 has such a longitudinal and cross size that makes it suitable to be fit on the end of thestem14 of thecircular stapler10 opposite the handle12 (FIGS.2A and41-44).

Advantageously, achannel22 crosses theanvil16 in a longitudinal direction and is suitable to receive a guide wire, not illustrated inFIG. 2. An exemplary use of theanvil16 for thecircular stapler10 will be described below with particular reference toFIG. 26-29. An anchoring ring suitable to lock theanvil16 on the guide wire on which it is fitted such as to be drawn by the guide wire in order to draw the tissues together and create the anastomosis has been designated with76.

InFIG. 3, with24 has been generally designated a positioning device suitable to draw tissues together which have been subjected to enterostomy, and to place means for providing a passage (anastomosis) between the tissues that have been drawn together.

Thepositioning device24 comprises a first component, or proximal component, designated withnumeral26 and a second component, or distal component, designated withreference28. Preferably, thepositioning device24 extends along alongitudinal axis30.FIGS. 5,7 and8 illustrate perspective views of theproximal component26, whereasFIG. 6 illustrates a perspective view of thedistal component28.

In accordance with a possible embodiment, theproximal component26 is suitably shaped to be abutted against the edge of a first enterostomy in order to draw the tissues adjacent thereto against the tissues adjacent to a second enterostomy. Thedistal component28 is suitably shaped to be inserted through the enterostomies.

For clarity purpose, the first enterostomy will be also called herein below as the proximal enterostomy, whereas the second enterostomy will be also called the distal enterostomy. With reference to a possible embodiment, the first enterostomy can be a gastrostomy and the second enterostomy can be a jejunostomy. With reference to a different embodiment, the first enterostomy can be a proximal jejunostomy and the second enterostomy can be a distal jejunostomy.

In accordance with a possible embodiment, theproximal component26 has a substantially cylindrical outer structure. Acavity32 being formed at one of the bases of the cylindrical structure and longitudinally thereto, preferably has a first portion defined by a surface having the shape of atruncated cone32aand a second portion defined by acylindrical surface32b. Thecavity32 does not run through the entire length of theproximal component26, leaving abase wall34. Furthermore, the cross size of thecavity32 and theproximal component26 are preferably such as to leave an abutment surface, for example a planeannular surface26acontouring the cavity.

According to a possible embodiment, alug36, preferably cylinder shaped, extends along thelongitudinal axis30 from the bottom of thecavity32 towards the outside of the cavity, preferably such that afree end36aof thelug36 is completely out of thecavity32. In other words, the length of thelug36 from the base ofcavity32 to thefree end36athereof is preferably greater than the depth of thecavity32. Thelug36 has a preferablycylindrical cavity38 extending along thelongitudinal axis30 and crossing thebase wall34 leading to the opposite surface of theproximal component26. In other words, thecavity38 involves thelug36 andbase wall34 thereby generating a duct open at the ends thereof and suitable to receive a guide wire not illustrated inFIG. 3-8. Preferably, theproximal component26 comprising thelug36 is made as one piece.

According to a possible embodiment, theproximal component26 comprisesholes40 for example for a suture, which can be used for separating the proximal component from the distal component, to be passed therethrough.

In accordance with a possible embodiment, thedistal component28 comprises ahead42 and astem44, which are preferably made as one piece, that develop along thelongitudinal axis30.

Thehead42 preferably has a shape of a truncated cone and, according to a possible embodiment, comprisesholes46 for a suture, which can be used for example to separate the distal component from the proximal component, to be passed therethrough.

In accordance with a possible embodiment, thestem44 preferably has a cylindrical structure and a free end thereof, i.e. opposite thehead42, widens to form a preferablyannular base48.

Achannel50 extends along thelongitudinal axis30 from the end ofhead42 to thebase48 and is suitable to receive a guide wire therein, not illustrated inFIG. 4 or6. The cross size ofchannel50, at least in the portion at thebase48, are such as to receive thelug36 of theproximal component26 therein. In other words, thechannel50 preferably has a larger section at the area in which it receives thelug36. Preferably, the remaining part ofchannel50 has the same cross size as thecavity38.

FIGS. 3 and 4 illustrate thepositioning device24 when assembled. Theproximal component26 and thedistal component28 are joined such that thecavity38 andchannel50 define a channel running all along the assembly for introducing a guide wire, not illustrated inFIGS. 3 and 4. Particularly,FIG. 4 illustrates thepositioning device24 sectioned along a plane comprising thelongitudinal axis30. In the assembly position, theproximal component26 and thedistal component28 lock anelastic ring52 therebetween, which is hold in a compressed/deformed configuration, and suitable to be placed by thepositioning device24 in a desired anastomotic site in which, after it has been positioned, theelastic ring52 takes a preset non-compressed rest shape (see for exampleFIG. 37). The elastic ring can be made of Nitinol, stainless steel or other satisfying materials.

In accordance with a possible embodiment, theelastic ring52 in its deformed configuration, has an end, such as the proximal (designated with numeral52a), that is locked between the base48 of thedistal component28 and the inner diameter of thecavity32 of theproximal component26, i.e. inside thecylindrical portion32bof thecavity32. The opposite end of theelastic ring52, i.e. the distal end designated with the numeral52b, is preferably unfastened and abuts beneath thehead42 of thedistal component28. In this case, it is advantageously provided that the cross size of thedistal end52bof theelastic ring52 does not exceed the cross size of thehead42 of thedistal component28.

An exemplary use of thepositioning device24 will be described below with particular reference to theFIG. 34-37. Upon use, the outer diameter of the proximal component, and particularly with the flatannular surface26a, is intended to act as a striker against the wall of the tissue to be drawn together, or in other words, abut against the proximal enterostomy while it minimizes the risk of penetration in the wall.

Thedistal component28, with itshead42, is intended to penetrate in the proximal and distal enterostomies and protects theelastic ring52 while being inserted and positioned, such as will be described in the following.

FIG. 9-12 illustrate a possible variant embodiment of thepositioning device24 and the proximal and distal components thereof according to the present invention. The elements in common have been designated with the same numeral used inFIG. 3-8 and will be described below with reference to the differences from the above embodiment.

Theproximal component26 is substantially similar to the one illustrated inFIGS. 3-5,7 and8. As regards thedistal component28, thestem44 extends straight up to its free end opposite thehead42 that does not widen to form a base similar to thebase48 of the distal component described above. Furthermore, thehead42, preferably having the shape of a cone or truncated cone, comprises aflange54 extending from the outer perimeter of the major base of the head to form a circular wall substantially parallel to thelongitudinal axis30.

FIGS. 9 and 10 illustrate thepositioning device24 when assembled, in which thechannel50 and thecavity38 define a channel extending along thelongitudinal axis30 through the entire length of the assembledpositioning device24 to receive a guide wire, not illustrated in theFIG. 9-12. In the assembled configuration of thepositioning device24, theelastic ring52 is hold between theproximal component26 and thedistal component28 in a compressed/deformed configuration. After the elastic ring has been positioned, it takes a preset, uncompressed rest shape as described above. In the deformed configuration, theproximal end52aof theelastic ring52 is fastened by the inner diameter of thecavity32, particularly by thecylindrical portion32bof thecavity32, whereas thedistal end52bof theelastic ring52 is fastened within thecircular flange54 of thedistal component28.

The cross size ofchannel50, at least in the portion at thebase48, are such as to receive thelug36 of theproximal component26 therein. In other words, thechannel50 has a larger section at the area where it receives thelug36. Preferably, the remaining part ofchannel50 has the same cross size as thecavity38. Also in this case, theelastic ring52 can be made of Nitinol (Ni—Ti alloy), stainless steel or other satisfying materials.

The exemplary use of the positioning device is similar throughout the various embodiments described.

FIG. 13-16 illustrate a possible variant embodiment of the positioning device and the proximal and distal components thereof according to the present invention. The elements in common have been designated with the same numeral used in the figures above and will be described below with reference to the differences from the above embodiments.

Theproximal component26 has a prismatic outer structure, preferably having a rectangular base. Thecavity32 is formed at one of the bases of the structure and does not run through the entire length of theproximal component26, leaving abase wall34. The sizes of thecavity32 andproximal component26 are such as to leave a peripheralflat surface26a.

In thebase wall34, preferably in the middle thereof, there is provided a preferablycylindrical cavity38 extending along thelongitudinal axis30 and crossing the entire thickness of the base wall.

Ribs56, preferably on opposite parts ofcavity38 and parallel to the long sides of the rectangular base, extend from the bottom of thecavity32 by a height preferably less than the depth ofcavity32.

According to a possible embodiment, theproximal component26 comprisesholes40 for example for a suture, which can be used for separating the proximal component from the distal component, to be passed therethrough.

Thedistal component28 comprises ahead42, which according to a possible embodiment, comprises holes (not illustrated) for a suture, which can be used for example to separate the distal component from the proximal component, to be passed therethrough.

Thechannel50 extends along thelongitudinal axis30 throughout the solid thickness of thehead42, preferably in the middle thereof, and is suitable to receive a guide wire therein, not illustrated inFIG. 14 or15.

Thehead42 has a tract having a substantially pyramidal or having a truncated-pyramid shape, preferably with a rectangular base. Twoflanges54 that preferably involve the short sides of the rectangular base and a limited portion of the long sides extend from the outer periphery of the major base of the truncated-pyramidal portion, in a direction substantially parallel to thelongitudinal axis30.

According to a possible embodiment, there is provided a preferablyflat extension58, arranged at a middle portion of each long side of the rectangular base and projecting in the direction substantially parallel to thelongitudinal axis30 along a preferably longer tract than theflanges54.

FIGS. 13 and 14 illustrate thepositioning device24 when assembled, in which thechannel50 and thecavity38 are arranged along thelongitudinal axis30 to receive a guide wire, not illustrated in theFIG. 13-16. In the assembled configuration of thepositioning device24, theelastic ring52 is hold between theproximal component26 and thedistal component28 in a preferably flattened, compressed/deformed configuration. After the elastic ring has been positioned, it takes a preset, uncompressed rest shape as described above. In the deformed configuration, theproximal end52aof theelastic ring52 is fastened by the inner periphery of thecavity32. Particularly, theribs56 fasten theelastic ring52 in a flat deformed configuration, or in other words, theelastic ring52 is arranged between the wall of thecavity32 and theribs56. Furthermore, thedistal end52bof theelastic ring52 is fastened by theflanges54 andextensions58, when the latter are provided.

On the one hand, the assembled configuration of thepositioning device24 is ensured by the interference between theproximal end52aof theelastic ring52 and the walls of theproximal component26 defining thecavity32, and on the other hand by the interference between thedistal end52bof theelastic ring52 and theflanges54 and theextensions58, when the latter are provided.

Also in this case, theelastic ring52 can be made of Nitinol, stainless steel or other satisfying materials.

The exemplary use of the positioning device is similar throughout the various embodiments described. In this latter case, theperipheral wall26aof theproximal component26 is the one intended to abut against the wall of the tissue to be drawn together while minimizing the risk that the wall may be penetrated. Furthermore, theangled head42 of thedistal component28 is intended to penetrate the proximal and distal enterostomies and protects theelastic ring52 when being introduced and positioned by fastening the ring within theflanges54 and theextensions58, such as will be described in the following.

Thechannel50 and thecavity38 are intended to house a guide wire for transporting the positioning device.

The present invention further relates to a method for the therapy of obesity and particularly a method for carrying out anastomosis in tracts of the digestive tube.FIG. 17-40 illustrate several steps of a possible embodiment of the method according to the present invention. The examples illustrated particularly relate to a method for carrying out an endoluminal/transluminal gastrojejunostomy (G-J) and a jejunojejunostomy (J-J) via transoral access.

In general terms, the method according to the present invention advantageously provides to draw tissues together and carry out anastomosis via endoluminal access by introducing, through a natural orifice (such as nose, mouth, ears, anus) or other luminal structures, guide or rail means within the tissues to be drawn together. Suitable components or devices can be thereby carried to the anastomotic site such that the surfaces of the tissues are suitably drawn together and connected with a channel (anastomosis).

Advantageously, the guide or rail means, particularly a main guide wire or first guide wire, are introduced such as to generate an open ring that can begin and end in natural orifices, such as the mouth, nose, anus or other natural orifices, such as colostomy, trocar, abdomen incisions, wounds, fistulae. The components or devices provided to draw the tissues together are advantageously moved by locking the device on the guide wire and pulling one of the guide wire ends.

In accordance with a possible embodiment, the ends of the open ring and accordingly of the main guide wire are different from each other, and hence distinguishable. Advantageously, the guide wire is internally hollow, i.e. it has a tubular structure suitable to receive needles for perforating the tissues and carrying out proximal and distal enterostomies. Perforation can take place for example either by pushing the needle through the tissues, or applying a radiofrequency through the needle.

The open ring then crosses the proximal enterostomy and then the distal enterostomy, for example by using a gripping device.

Thepositioning device24 is locked on the guide wire by means of an anchoringring76 and drawn by the guide wire until it is partially inserted in the proximal enterostomy and abutted against a first tissue portion to be joined. Thepositioning device24 is further drawn until it is partially inserted in a distal enterostomy by drawing together the tissue portions to be joined. Finally, thepositioning device24 partially inserted in the proximal and distal enterostomy releases anelastic ring52 riding the proximal and distal enterostomies to hold the tissue portions joined to each other thereby generating a passage or anastomosis.

With reference to the above example,FIG. 17-29 illustrate a gastrojejunostomy (G-J) step that is advantageously carried out by introducing guide or rail means through a natural orifice (such as the nose or mouth). Subsequently, the guide means, a guide wire in this case, form an open ring crossing the points of the tissues to be joined.

FIG. 17 illustrates a first step, which is designated as the step1, in which a substantiallyconventional laparoscope60 has been introduced in the abdominal cavity to view the areas to be treated. This step can be potentially eliminated after a certain degree of skill in the method has been achieved, thereby the method can be made completely endoluminal and transluminal. Thelaparoscope60 is illustrated inFIG. 17 and also in the subsequent steps, but it can be omitted as well. Alternatively or in addition to the laparoscopic control, a gastroscopic control can be provided, i.e. by introducing a secondary gastroscope for example through the esophagus or mouth having the function of controlling the method steps. In case a gastroscope is required to carry out several steps of the method, a main gastroscope carrying out the method steps and a secondary gastroscope monitoring the operation will be introduced.

FIG. 18 illustrates a step of the method according to the present invention, which is also designated as the step2, in which a substantially conventionalmain gastroscope62 is introduced through the esophagus, stomach, passing through the pylorus and subsequently the duodenum to reach the jejunum. Particularly, thegastroscope62 is advanced by approximatively 20-40 cm beyond the pylorus.

FIG. 19 illustrates a detail of the jejunum and the end of thegastroscope62. The latter conventionally comprisesseveral channels64 crossing the entire length thereof and that can be used for tools or the like to be passed therethrough. The step fromFIG. 19, also designated as the step3, provides that afirst guide wire66 or main guide wire being suitable to provide the open ring is advanced along one of thechannels64 of thegastroscope62. The guide wire is advanced until apointed end66athereof or a needle sliding along the tubular structure of the guide wire protrudes from the gastroscope. Theend66aof theguide wire66 perforates the jejunum wall from the inside and creates a jejunostomy (proximal enterostomy). Thelaparoscope60 is optionally provided. When this is provided, theguide wire66 is advanced and the jejunostomy is created under the laparoscope visual control.

The jejunostomy can be carried out by pushing the guide wire directly through the jejunum wall. Alternatively, or in addition thereto, radiofrequency energy may be applied to perforate the jejunum wall and then advance theguide wire66.

In other words, afirst guide wire66 being part of guide or rail means which will be subsequently indicated in greater detail, is positioned within the tissue to be joined and passed through one of the tissue portions to be joined. The jejunum tissue portion to be drawn near and joined to the stomach thereby forming an anastomosis has been designated with A.

FIG. 20 illustrates a step which has been designated as the step4 in which thegastroscope62 is removed and theguide wire66 is left in the abdomen within the stomach and along a jejunum tract with theend66aprotruding from the jejunum at the tissue portion A to be joined. The step4 can be carried out under laparoscopic control (laparoscope60), when provided.

FIG. 21 illustrates a step which is designated as the step5, in which amain gastroscope62, of a substantially conventional type, has been introduced again in the stomach through the esophagus, in order to create a gastrostomy (distal enterostomy). Also in this case, one may directly push either asecondary guide wire77 with apointed end77aor a needle sliding within the tubular structure of the guide wire. Alternatively, or in addition thereto, radiofrequency energy can be applied in order to perforate the stomach wall and advance the guide wire.

The gastrostomy is carried out in a stomach portion corresponding to the area to be joined. This portion has been designated with A′.

Step5 may also be carried out under laparoscopic control.

FIG. 22 illustrates a step of the method according to the present invention, which has been designated as the step6, in which the gastrostomy is enlarged by means of aballoon catheter72. The catheter is inserted in thegastroscope62 until a balloon-end72athereof reaches the gastrostomy which is enlarged by inflating the balloon.

Step6 may also be carried out under laparoscopic control.

FIG. 23 illustrates a step of the method according to the present invention, which has been also designated as the step7, in which thegastroscope62 is advanced through the gastrostomy enlarged by the balloon, within the abdominal cavity. Step7 can be carried out either under gastroscopic (secondary gastroscope) and/or laparoscopic (laparoscope60) control. As stated above, by gastroscopic control is meant a control carried out by means of a secondary gastroscope, not illustrated inFIG. 23, which is introduced through the esophagus having only a control function. This secondary gastroscope can be provided in every step whenever a gastroscopic control as an alternative or in addition to the laparoscopic control is required.

FIG. 24 illustrates a step which has been designated as the step8, in which a gripping device74 (forceps or the like) is advanced through thegastroscope62 and theend66aof theguide wire66 protruding from the jejunostomy is coupled therethrough. Gripping the guide wire point is not required.

Thegripping device74 can be for example a loop-shaped endoscopic instrument for polypectomies.

FIG. 25 illustrates a step which has been designated as the step29, in which theguide wire66 of the jejunum is pulled through the gastrostomy in order to provide afirst ring80 open at the ends thereof, or gastro-jejunum ring (ring1), the ends thereof protruding from the orifice used (the mouth, esophagus, . . . ). InFIG. 25, the end ofring80 corresponding to the jejunum (jejunum end), i.e. the end passing through the stomach and jejunum and protruding from portion A has been designated with80a, whereas the end of thering80 corresponding to the stomach (stomach end), i.e. the end passing through the stomach and protruding therefrom at portion A′ has been designated with80b. Both ends are advantageously different from each other in order to be distinguished.

Thering80 can be now used as a guide means or rail system in order to introduce and carry suitable anastomotic devices suitable to draw the tissues together and carry out the anastomosis in the site of interest. The anastomotic devices are advantageously locked on the guide wire for example by means of an anchoringring76 and one of the ends of the ring is pulled until the anastomotic device partially enters the proximal enterostomy, draws the tissues thereof near the distal enterostomy and partially enters the same.

FIG. 26 illustrates a step which has been designated as thestep10, wherein the selected anastomotic device (anvil16,positioning device24, etc.) is inserted on the guide wire from the jejunum end80aand pulled along thering80 of guide wire through the esophagus, stomach, duodenum and jejunum. Drawing is allowed by an anchoringring76 which is made integral with the guide wire such as to push against the proximal part of the selected anastomotic device.

Though ananvil16 has been illustrated inFIG. 26, apositioning device24 or other similar devices can be used as well.

By pulling the guide wire from the end ofstomach80b, the anastomotic device can be pulled until the portion A of the jejunum (proximal enterostomy).

As illustrated inFIG. 26, the end of the jejunum part of theguide wire80ais inserted in thechannel22 of theanvil16 from the side of thestem18. In the case of thepositioning device24, the end of the jejunum part of theguide wire80awould be inserted in thechannel50 from the side of thedistal component28.

FIG. 27 illustrates a step which has been also designated as the step11, in which the anastomotic device and particularly theanvil16 is pulled until it has partially passed the jejunostomy (proximal enterostomy). As already stated above, one can act under laparoscopic control. Thestem18 of theanvil16 crosses the jejunostomy and protrudes in the abdominal cavity, whereas thehead20 contacts the tissue to be drawn together. When apositioning device24 is used, the head would enter the jejunostomy whereas the flatperipheral surface26awould abut against the contouring tissues.

FIG. 28 illustrates a step which has been also designated as thestep12, in which by keeping on pulling the end of theguide wire80bfrom the side of the stomach, theanvil16 and particularly thehead20 acts as a striker against the inner wall of the portion A of the jejunum and draws the jejunum until the portion A is drawn near the stomach and particularly portion A′. Thestem18 of the anvil16 (anastomotic device) also partially enters the gastrostomy (distal enterostomy). The operation can be carried out under laparoscopic control (laparoscope60). When apositioning device24 is used, the head would42 enter the gastrostomy whereas the flatperipheral surface26awould draw the relative contouring tissues together.

FIG. 29 illustrates a step which has been indicated as the step13, in which the traction on thestomach end80bof the guide wire is maintained in order to maintain the portions A and A′ near each other. Furthermore, acircular stapler10 is caused to slide on the guide wire from thestomach end80buntil it reaches the inside of the stomach, and until thestem18 of theanvil16 connects to the end of thestem14 of the stapler10 (such as illustrated in greater detail inFIGS. 2aand41-44). Thestapler10 carries out the anastomosis between the portion A and the portion A′ by cutting and suturing the tissue in a circular manner. Apassage84 is thereby formed (FIG. 30) which directly communicates the stomach and jejunum. When apositioning device24 is used, thepassage84 is obtained by detaching the proximal component from the distal component and releasing theelastic ring52 riding both enterostomies.

When the gastrojejunostomy (G-J) has been completed, theguide wire66 is removed by drawing one end thereof.

With reference to the above example,FIG. 30-40 illustrate a jejunojejunostomy (J-J) step that is advantageously carried out by introducing guide or rail means through a natural orifice (such as the esophagus or mouth). Subsequently, the guide means, a guide wire in this case, form an open ring crossing the points of the tissues to be joined.

FIG. 30 illustrates a step designated as thestep14, in which a substantiallyconventional gastroscope62 is introduced through the esophagus, stomach, passing through the pylorus and subsequently the duodenum to reach the jejunum. Particularly, thegastroscope62 is advanced to a portion to be joined that is designated with B in order to carry out a proximal jejunostomy, which portion is proximally arranged relative to channel84 (anastomosis) that has already been created.

Aguide wire86, or main guide wire, intended to form the open ring is advanced along achannel64. The guide wire is advanced until apointed end86athereof or a needle sliding within the guide wire protrudes from the gastroscope. Theend86aof theguide wire66 perforates the jejunum wall from the inside and creates a jejunostomy (proximal enterostomy).

Thelaparoscope60 is optionally provided. When this is provided, theguide wire86 is advanced and the jejunostomy is created under the laparoscope visual control.

The jejunostomy can be carried out by pushing the guide wire directly through the jejunum wall. Alternatively, or in addition thereto, radiofrequency energy may be applied to perforate the jejunum wall and then advance theguide wire86.

In other words, aguide wire86 being part of guide or rail means which will be subsequently indicated in greater detail, is positioned within the tissue to be joined and passed through one of the tissue portions B to be joined (proximal jejunostomy).

FIG. 31 illustrates a step which has been indicated as the step15, in which thegastroscope62 is removed and theguide wire86 is left within the stomach and jejunum, with theend86aprotruding from the walls of the jejunum (proximal jejunostomy). Thegastroscope62 is then advanced through the stomach, the previously accomplished gastrojejunostomy (step84) and a tract of the distal jejunum until a sufficient distance to create the jejunumjejunum (J-J) anastomosis. The latter portion has been indicated with the reference B′. Analogously toFIGS. 21 and 22 (steps5 and6) a secondary guide wire is advanced along thegastroscope62 until a pointed end thereof protrudes from the end of thegastroscope62. This pointed end is then passed through the tissue walls at the portion B′ in order to create a distal jejunostomy. The distal jejunostomy can be also carried out either by directly pushing the pointed end through the jejunum wall or applying radiofrequency energy in order to perforate the wall, subsequently advancing the guide wire.

The creation of the distal jejunostomy can be monitored through the laparoscope.

A catheter with balloon-end may be optionally inserted along the gastroscope. When the balloon end is near the distal jejunostomy, the balloon is inflated in order to dilate the distal jejunostomy and the gastroscope is pushed in the abdominal cavity. This dilation may be required when the laparoscope is not used and monitoring is carried out through the gastroscope such that the latter can view theend86aof theguide wire86.

FIG. 32 illustrates a step which has been designated as thestep16, in which a gripping device74 (endoscopic forceps or the like) similar to the one used in step8, is advanced through the gastroscope to lock theend86aof themain guide wire86 protruding from the proximal jejunostomy site. Gripping the guide wire end is not required.

FIG. 33 illustrates a step which has been indicated as the step17, in which the gastroscope has been removed and themain guide wire86 has been pulled through the distal jejunostomy to form aring88 open at the ends thereof, or jejunumjejunum ring (the ring2), the ends thereof protruding from the orifice used. InFIG. 33 the end of the jejunum, i.e. the end passing through the stomach and the jejunum and protruding therefrom at portion B has been designated with88a, whereas the end of the stomach, i.e. the end passing through the stomach, protruding from the gastrojejunostomy (passage84) and protruding from the jejunum at portion B′ has been designated with88b.

Thering88 can be now used as a guide means or rail system in order to introduce and carry suitable anastomotic devices suitable to draw the tissues together and carry out the anastomosis in the site of interest (J-J). As described above, the anastomotic device is locked on the guide wire, an end thereof being pulled in order to advance the anastomotic device.

FIG. 34 illustrates a step which has been designated as thestep18, wherein an anastomotic device such as apositioning device24 is inserted from the jejunum end88aand pulled along thering88 of guide wire through the esophagus, stomach, duodenum and jejunum. The operation may be carried out under laparoscopic and/or gastroscopic control in order to view the movement.

The anastomotic device may be caused to slide on the guide wire from the jejunum end88a. Traction is permitted due to an anchoring ring similar to that described above, which is made integral with the guide wire pushing against the proximal part of the selected anastomotic device. By pulling the guide wire from the end ofstomach88b, the anastomotic device can be pulled until the portion B of the jejunum.

As illustrated inFIG. 34, the positioning device24 (channel50 and cavity38) is inserted on theend88aof the guide wire from the side of thedistal component28.

The anastomotic device and particularly thepositioning device24 is pulled until it has partially passed the proximal jejunostomy. Thehead42 of thedistal component28 and a part of theelastic ring52 cross the proximal jejunostomy and protrude in the abdominal cavity, whereas the other part of theelastic ring52 remains within the jejunum. The proximal component also remains within the jejunum and abuts, for example with thesurface26a, against the tissue wall to act as a striker.

FIG. 35 illustrates a step which has been designated as the step19, in which the two jejunum branches are drawn together, optionally under gastroscopic and/or laparoscopic vision by keeping on pulling the anastomotic device (positioning device24).

Particularly, thehead42 of thedistal component28 with a part of theelastic ring52 penetrate in the distal jejunostomy.

FIG. 36 illustrates a step which has been designated as thestep20, in which theelastic ring52 that takes its uncompressed configuration, such as illustrated enlarged for example inFIG. 37 (step21) is positioned. The ends of theelastic ring52 fold between the proximal jejunostomy and the distal jejunostomy thereby maintaining the portion B and portion B′ joined to each other thereby creating a circular anastomosis. Theelastic ring52 can be released from thepositioning device24 by simultaneously uncoupling the distal andproximal components26 and28. Alternatively, one of the two components can be uncoupled by pulling the same while keeping unchanged the position of theelastic ring52 relative to the anastomotic site.

To uncouple the distal component and the proximal component, one can use the suture threads protruding from theholes40 of theproximal component26 and theholes46 of thedistal component28 by coupling them by means of a suitable tool inserted in agastroscope62. The suture stitches are thus gripping points for uncoupling the proximal and distal components of thepositioning device24 from each other.

During positioning, the enterostomy can be viewed by means of a gastroscope or laparoscope.

When the jejunojejunostomy (J-J) has been completed, theguide wire86 is removed by drawing one end thereof.

FIG. 38 illustrates a step which has been designated as thestep22, in which the gastrojejunostomy (G-J) and the jejunojejunostomy (J-J) have been completed and in which there is illustrated the route followed by the food along the digestive tract after it has been changed.

To complete the method discussed above, either a gastric partition obtained with a gastric bandage such as illustrated inFIG. 39 (step23.1) or a gastric partition obtained with an endoscopic stapler such as illustrated inFIG. 40 (step23.2) can be provided.

From what has been described above, one may appreciate how the provision of guide means carrying components or devices to the desired anastomotic site through natural orifices (such as the nose, mouth, ear, anus) or other luminal structures in order to carry out anastomosis greatly simplifies the procedure, shortens the patient's convalescence and eliminates the drawbacks of traditional surgery.

The provision of components and devices that suitably draw the tissue surfaces together and/or connect the surfaces by means of a passage is particularly advantageous and allows to carry out a completely endoluminal method.

It should be understood that variations and/or additions to what has been described and illustrated above may be provided.

In addition to the method described above, there may provided alternative procedures (ERCP, Chole duct, colo-proctostomy, jejunum-colostomy).

The order of the steps of the method illustrated in the annexed drawings and described above, (gastrojejunostomy or G-J, jejunojejunostomy or J-J, sectioning) can be readapted. For example, with patients that have already been subjected to gastric bandage, the steps G-J and J-J can be completed as described above. Subsequently, the gastric bandage can be completely restricted by carrying out a gastric partition thereby completing the procedure.

Alternatively to the use of thecircular stapler10 andanvil16, the gastrojejunostomy G-J according to the steps described above (FIG. 17-FIG.29) can be carried out by means of apositioning device24 as described above (similarly to the jejunojejunostomy J-J steps corresponding toFIG. 31-38).

To the preferred embodiment of the device, stapler or method described above, those skilled in the art, aiming at satisfying contingent and specific requirements, may carry out a number of modifications, adaptations and replacement of elements with others functionally equivalent, without however departing from the scope of the claims below.

Claims (6)

1. A method for carrying out anastomosis in tracts of the digestive tube comprising the steps of:

introducing through a natural orifice a guide means into first and second tissues portions to be drawn near and joined and, subsequently

inserting an anvil of a circular stapler along the guide means, securing said anvil with respect to said guide means and drawing said anvil by means of said guide means against said second tissue portion;

drawing said first and said second tissue portions together by pulling on said guide means to move said anvil together with said second tissue portion towards said first tissue portion; and

further including the step of introducing a secondary guide to create a distal opening by causing a needle to slide within a tubular structure of said secondary guide wire, said needle perforating the tissue.

2. The method according toclaim 1, further including the step of creating a proximal opening and a distal opening by causing a needle to slide within a tubular structure of said guide means to perforate the tissue.

3. The method according toclaim 1, further including the step of inserting a gripping device through said distal opening and gripping the end of the guide means with said gripping device.

4. A method for carrying out anastomosis in tracts of the digestive tube comprising the steps of:

introducing through a natural orifice a guide means into first and second tissues portions to be drawn near and joined and, subsequently

inserting an anvil of a circular stapler along the guide means, securing said anvil with respect to said guide means and drawing said anvil by means of said guide means against said second tissue portion;

drawing said first and said second tissue portions together by pulling on said guide means to move said anvil together with said second tissue portion towards said first tissue portion; and further comprising a step of carrying out a gastrojejunostomy comprising the steps of:

introducing the guide means through a natural orifice or other orifice within the stomach and jejunum, and

shaping the guide means into a first open ring having first and second ends leading to said orifice, placing said first ring across a proximal opening and a distal opening, and actuating said first ring to create a gastrojejunostomy.

5. The method according toclaim 4, wherein said guide means is introduced through the esophagus, stomach and a tract of the jejunum and is passed through the jejunum wall.

6. The method according toclaim 5, wherein the further comprising the step of causing a needle to slide within a tubular structure of the guide means so as to perforate the tissue.

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